AbbVie announced that Health Canada has approved a new 6-month 45mg strength of LUPRON DEPOT (leuprolide acetate for extended-release injectable suspension) for the treatment of advanced prostate cancer. The approval expands the available dosing options to four intervals: 7.5 mg (1-Month), 22.5 mg (3-Month), 30 mg (4-Month), and the newly approved 45 mg (6-Month) formulation.
LUPRON DEPOT was initially approved by Health Canada for advanced prostate cancer in 1989, providing 36 years of proven clinical use in Canada. The hormonal medication is a synthetic gonadotropin-releasing hormone (GnRH) analog that suppresses the body's production of sex hormones like testosterone and estrogen with continuous use.
Clinical Impact and Patient Benefits
"Advanced prostate cancer can have a devastating impact on patients and their quality of life," said Dr. Andrew Loblaw, Clinician Scientist and Head of Genitourinary Radiation Oncology Clinical Studies Group. "As a physician, I am pleased to know that my patients will be able to access a treatment that helps reduce the administration burden many often experience. This announcement marks a significant advancement in how we treat and manage advanced prostate cancer for years to come."
The extended 6-month dosing interval is designed to reduce the frequency of clinic visits and injections, potentially improving patient convenience and treatment adherence while maintaining therapeutic efficacy.
Disease Burden and Market Context
Prostate cancer represents a significant health challenge in Canada, being the most prevalent cancer among Canadian men and accounting for one in five new cancer case diagnoses. Statistics indicate that one in eight Canadian men will develop prostate cancer during their lifetime. Despite its high prevalence, most cases are treatable, particularly when detected early.
"At AbbVie, we strive to have a remarkable impact on people's lives," said Rami Fayed, Vice President and General Manager of AbbVie Canada. "With over three decades of improving the lives of Canadians living with advanced prostate cancer, this announcement reflects our long-term commitment to putting patients first and creating possibilities for communities."
Therapeutic Mechanism and Applications
LUPRON DEPOT is approved by Health Canada for various conditions beyond advanced prostate cancer, including endometriosis, uterine fibroids, and central precocious puberty. As a GnRH analog, the medication works by continuously suppressing the body's natural hormone production, which is particularly relevant in hormone-sensitive cancers like prostate cancer.
AbbVie's Oncology Portfolio
AbbVie is advancing a comprehensive oncology pipeline with more than 35 investigational medicines in multiple clinical trials across various cancer types. The company's oncology strategy focuses on targeted treatment modalities including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibodies, and novel CAR-T platforms for both blood cancers and solid tumors.
